Exhibit 10.27


 





AMENDED AND RESTATED


EXCLUSIVE LICENSE AGREEMENT


Between


THE ARIZONA
BOARD OF REGENTS ON BEHALF OF THE UNIVERSITY OF ARIZONA


And


CANCER PREVENTION PHARMACEUTICALS,
INC.


 


 


THIS
AMENDED AND RESTATED EXCLUSIVE LICENSE AGREEMENT (this
"AGREEMENT" ), effective as of the date of the
last authorized signature affixed hereto, is by and between the Arizona Board of Regents, a
body corporate of the State of Arizona on
behalf of The University of Arizona having its principal
offices at Tucson, Arizona 85721 ("ARIZONA"),
and Cancer Prevention Pharmaceuticals, Inc., a Delaware corporation having its principal office
at 1760 E. River Road, Suite 250, Tucson, AZ 85718 ("LICENSEE"), successor in interest to Cancer Prevention Pharmaceutical,
LLC, an Arizona limited liability company (“CPP LLC”).


 


PREAMBLE


 


Whereas,
good and valuable inventions jointly developed at the University
of California, Irvine ("UCI") and ARIZONA are claimed
in Patent Rights, as defined below; and


 


Whereas,
inventors, who were employees of
ARIZONA or UCI when the inventions were developed, have assigned, or shall assign,
to their respective employers all of their right, title and interest in the inventions; and


 


Whereas,
ARIZONA and The Regents of the University of California
on behalf of the University of California-Irvine, entered
into an Inter-institutional Agreement, effective May 4 2001, that authorizes
ARIZONA to act on behalf of UCI in licensing
Patent Rights to a third party; and consequently in this Agreement,
ARIZONA and UCI shall be
referred to collectively as "UNIVERSITIES";
and


 


Whereas,
LICENSEE and ARIZONA earlier entered into that certain Exclusive License Agreement made effective
May 28, 2009 (the “Original Effective Date”) by which ARIZONA granted to LICENSEE
an exclusive license to
Patent Rights for the use of Licensed Product
and for the useful management of Licensed Product so that the inventions may be developed and
the benefits enjoyed by the public, which agreement was
first amended by that certain First Amendment made effective September 16, 2009, and further amended by that certain Second Amendment
made effective January 14, 2010, and further amended by that certain Third Amendment made effective April 12, 2010, and last amended
by that certain Fourth Amendment made effective October 15, 2010 (collectively, the “Original License Agreement”);
and


 


Whereas,
for good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, LICENSEE and ARIZONA desire
to amend the Original License Agreement and restate it in its entirety by way of this AGREEMENT, LICENSEE and ARIZONA hereby agree
as follows:





 








	Arizona's First University - Since 1885.	 



 






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ARTICLE
1


Definitions


 


		1.1	"Affiliate" means any entity that owns
or controls at least
fifty (50) percent of, or of which fifty (50)
percent or more
is owned or controlled, by LICENSEE.



 


		1.2	“Develop” means to conduct scientific, technical and
regulatory activities, including but not limited to pharmaceutical formulation development, pre-clinical, toxicological, process
development for manufacturing, making regulatory filings and seeking regulatory approvals, and clinical studies, but does not include
routine manufacturing.



 


		1.3	"Effective Date" means the date of last
signature by authorized representatives of the two parties affirming acceptance of the terms and conditions of this Agreement.



 


		1.4	"Fields of Use" means all fields of use
of the Technical Information and all fields of use of the inventions claimed in the Patent Rights.



 


		1.5	"Inventor" means an inventor identified
as such with respect to any of the Patent Rights.



 


		1.6	"Licensed Product" means any product or
method:



 


		1.6.1	that is covered by Patent
Rights, to the
extent that the manufacture, use, sale, offer for sale or importation of such product or method would infringe an
issued claim of Patent Rights (including, but not limited to,
inducement or contributory
infringement), but for
the license granted to LICENSEE under this Agreement; or



 


		1.6.2	the development, manufacturing, regulatory approval, labeling, use,
marketing, sale or commercialization of which has been supported by, or benefitted from the access to, any Technical Information.



 


		1.7	"Patent Rights" means: (a) the patents
and patent applications identified in Schedule 1 attached to this Agreement, and any patents or patent applications that
may be added to this Agreement (and Exhibit A) by separate agreement of the Parties; (b) all divisional or continuation,
in whole but not in-part, applications based on any of the foregoing; (c) any and all foreign applications corresponding to applications
described in (a) or (b) above; (d) any and all issued and unexpired patents resulting from any of the applications described in
(a) or (b) above; and (e) any and all issued and unexpired foreign patents, reissues, reexaminations, renewals, extensions or patent
term restoration that may be based on any of the patents described in (a) or (d) above.



 


		1.8	“SUBLICENSEE(S)” means any person or
entity sublicensed, or granted an option for a sublicense, by LICENSEE under this Agreement.



 


		1.9	"Technical Information" means UNIVERSITIES’
information and know-how made available to LICENSEE:



 


		1.9.1	in tangible form, including without limitation, documented
research data or information; clinical trial data including, but not limited to, data generated by NIH Clinical Trial # NCT00005882
and NCT00118365; or other written procedures or methods and protocols related to Licensed Products and Patent Rights;
or



 






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		1.9.2	through services by ARIZONA or ARIZONA employees
acting as consultants or on behalf of COMPANY in any capacity, with ARIZONA's approval that teach or transfer to LICENSEE ARIZONA
know-how or information;
or



 


		1.9.3	through transfers of ARIZONA personnel associated
with the project to LICENSEE or Affiliates.



 


		1.10	"Territory" means worldwide.



 


ARTICLE 2


Grant


 


		2.1	Grant of Rights. ARIZONA grants to LICENSEE
an exclusive license to Develop, make, have made, import, have imported, use, market, sell, offer to sell, and distribute Licensed
Product under the Patent Rights, and a non-exclusive license to Technical Information to Develop, use, label, market, sell, to
make regulatory filings, and seek regulatory approval of, and otherwise commercialize Licensed Product within the Fields of Use
and in the Territory. ARIZONA shall not provide clinical trial data generated
by NIH Clinical Trial #NCT00005882 and #NCT00118365 as described in Paragraph 1.8.1, to third parties for regulatory or commercial
purposes. These rights are subject to the terms and conditions set forth herein. This grant does not relinquish UNIVERSITIES’
ownership in or rights to Licensed Product in the Fields of Use, Patent
Rights or Technical Information and does not grant to LICENSEE, by implication or otherwise, any rights to any other technologies
owned, invented, or discovered by UNIVERSITIES, whether past, present or future .



 


		2.2	Sublicenses.
ARIZONA grants LICENSEE the right and power to issue sublicenses to third
parties under the rights and licenses granted under Paragraph 2.1 above. LICENSEE’s right and power to issue sublicenses
shall only be in effect as long as LICENSEE possesses an exclusive license under the Patent Rights under this Agreement. Any and
all sublicense agreements granted by LICENSEE: (a) shall be consistent with this Agreement; (b) may not grant to SUBLICENSEE any
rights broader or inconsistent with the rights set forth in this Agreement and; (c) to the extent applicable, must include all
of the rights and obligations due ARIZONA in this Agreement, including the following Sections: 2.3, 2.4, 3, 5.1, 11, and 12. LICENSEE
shall notify ARIZONA of each sublicense granted hereunder and provide ARIZONA with a copy of each sublicense, subject to the same
obligations of confidentiality imposed on LICENSEE under the pertinent sublicense. LICENSEE shall collect and pay all fees due
ARIZONA and guarantee all such payments due from SUBLICENSEEs. LICENSEE
shall require SUBLICENSEEs to provide payments with financial reports to the extent required of LICENSEE hereunder, and LICENSEE
shall collect and summarize for ARIZONA all such reports due from SUBLICENSEEs.
LICENSEE shall monitor SUBLICENSEEs and assure license terms are met.



 


		2.3	ARIZONA Reserved Rights.
ARIZONA shall retain the right for itself to use the Licensed Product
for ARIZONA's educational and internal research purposes. ARIZONA shall retain
the right to sublicense the rights for educational and internal research purposes to other institutions of higher education on
behalf of any of the Inventors named in the patents who are employees of ARIZONA, in the event that said Inventor moves to that
institution. However, nothing in this Paragraph 2.3 shall permit ARIZONA during the term of this Agreement to sell or lease embodiments
of the inventions.



 


		2.4	Publications. Nothing in this Agreement, except
the provisions of Article 13·regarding
Confidentiality of LICENSEE's information, shall
be deemed to limit the right of ARIZONA to publish, any and all technical data resulting from any research performed by ARIZONA,
including but not limited to, research relating to the Licensed Product or
Technical Information.
ARIZONA will provide
LICENSEE with all draft manuscripts describing unpublished
data at least forty five (45) days prior to submission for publication. If
requested by LICENSEE in order to permit the
preparation and filing of appropriate patent applications, ARIZONA
shall agree to an additional review period prior to submission of the draft manuscript to any outside entity, such additional period
not to exceed forty-five
(45) days.



 



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		2.5	Governing Laws.
The use of Licensed Product shall
be subject to applicable county,
state or federal laws, rules, and regulations governing use
of Licensed Product in or between any county, state or federal jurisdiction.



 


		2.6	Grant Limitations.
LICENSEE acknowledges that Licensed Product will not be used, marketed and/or
sublicensed outside the Fields of Use or Territory.



 


 


ARTICLE 3


Government
Rights


 


		3.1	Rights of Sponsor. The development of this
technology was sponsored in part by National Institute of Health Grant No.
PO1 CA072008 and Grant No.
P50 CA095060;
and as a consequence, this
license is subject to overriding obligations to the Federal Government
under 35 U.S.C. §200-212
and applicable implementing regulations, as well as the
payment -free provisions
of Paragraph 3.2 below.



 


		3.2	Payment-free
License to Government. Upon request of the U.S. Government, no payments
may be paid or collected for use of Licensed Product by the
U.S. Government or any agency thereof, as provided for in the license to the government.



 


ARTICLE 4


Fees and Warrants


 


		4.1	Fees.
In consideration, in part,
for the rights granted herein, LICENSEE shall pay the following fees:



 


		4.1.1	One-Time, Non-Refundable, Non-Cancelable, Non-Creditable
License Issue Fee. LICENSEE shall pay ARIZONA
a one-time, non-refundable, non-cancelable, non-creditable license issue fee of five thousand dollars ($5,000) within fourteen
(14) of the Original Effective Date. ARIZONA
acknowledges that LICENSEE timely complied with the foregoing obligation in connection with the execution and delivery of the Original
License Agreement.



 


		4.1.2	Warrants. LICENSEE shall grant ARIZONA
warrants as partial consideration for this License in accordance with the warrant agreement
attached hereto as Appendix A. ARIZONA
acknowledges that LICENSEE timely complied with the foregoing obligation in connection with the execution and delivery of the Original
License Agreement.



 


		4.1.3	License Maintenance Fee.
LICENSEE shall pay ARIZONA
License Maintenance Fees as follows:



 






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1st through
4th anniversary of the Original Effective Date: $5,000


5th through
7th anniversary of the Original Effective Date:
$10,000


8th through
10th anniversary of the Original Effective Date:
$25,000


 


Annual maintenance fee
payments will be fully creditable against any Milestone
Fees due in the same calendar year. No annual maintenance fees are due after the 10th anniversary of the Original Effective
Date.


 


		4.1.4	Milestone Fees. LICENSEE shall pay
ARIZONA Milestone Fees,
as follows: 



 


4.1.4.1
For Licensed Product claimed in
Patent Rights identified in Group I of Schedule 1:


 


		a)	$25,000 due upon receipt of U.S. Food and Drug Administration
("FDA") marketing approval through the
NDA (New Drug Application)
process by LICENSEE, Affiliate, assignee or SUBLICENSEE for
Licensed Product in Fields of Use
for prevention or treatment of Familial
Adenomatous Polyposis (FAP); and



 


		b)	$50,000
due upon receipt of FDA marketing approval by LICENSEE, Affiliate, assignee or SUBLICENSEE for Licensed
Product in Fields of Use for prevention or treatment of colon polyps, adenomas
or colorectal cancer.



 


		4.1.4.2	For License Product claimed
in Patent Rights identified in Group II of Schedule 1:



 


$15,000
due upon receipt of FDA marketing approval, through the PMA (Premarket Approval) application process, by LICENSEE, Affiliate, assignee
or SUBLICENSEE or approval by the Centers for Medicare & Medicaid Services (“CMS”) of a test under the Clinical
Laboratory Improvement Amendments for use with such Licensed Product.


  


4.2Patent Maintenance and Related Costs. LICENSEE agrees to accept, and is hereby granted the
corresponding rights and authority of, management and financial responsibilities for prosecution and maintenance of Patent Rights
and of any other patent rights as the parties may subsequently agree will be included within the scope of the licenses granted
hereunder. LICENSEE shall nominate, and ARIZONA shall promptly approve, which approval shall not be unreasonably withheld, conditioned
or delayed, patent counsel to prosecute and maintain such Patent Rights. ARIZONA acknowledges that it has approved Parker Highlander
PLLC as LICENSEE’s nominee for patent counsel. It is further agreed that LICENSEE shall instruct patent counsel to send to
ARIZONA, at the address and contact points specified in Art. 9, Notices, copies of all proposed patent correspondence with the
USPTO and foreign patent authorities at the time the same are communicated to LICENSEE. LICENSEE shall instruct patent counsel
to take into consideration ARIZONA’s comments received reasonably in advance of the pertinent deadline when responding to
a US or foreign patent office. ARIZONA and LICENSEE share a community of interest with regard to the prosecution of the Patent
Rights and, accordingly, ARIZONA shall treat all communications from LICENSEE’s patent counsel as confidential attorney-client
privileged communications.


 


If LICENSEE affirmatively
elects to abandon prosecution or maintenance of a particular patent application or patent in a particular country, ARIZONA will
be notified in sufficient time to assume responsibilities should ARIZONA decide to do so. LICENSEE shall bear all costs incurred
in the maintenance or prosecution of the pertinent patent or patent application, as the case may be, until such time as the ARIZONA
assumes responsibility for that patent prosecution, but in no event will LICENSEE be obligated to bear those costs incurred three
months after the date of LICENSEE’s abandonment notice to ARIZONA. If LICENSEE intentionally abandons any particular patent
application or issued patent as provided above, the licenses under Paragraph 2.1, Grant of Rights, shall terminate on the effective
date of that abandonment, whereupon said application or issued patent shall no longer be considered part of licensed Patent Rights
hereunder.


 






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		4.3	Payments. Payments
hereunder shall be made in United States dollars.



 


		4.4	Fee Payment Schedule. LICENSEE shall pay all
fees under Paragraph 4.1 annually within 30 days of December 31 of each calendar year. Each such payment shall be for the most
recently completed calendar year.



 


		4.5	Charge for Late Payment. In the event that
fee payments are not
received when due, the
LICENSEE shall pay additional interest charges at an annual rate of
ten percent (10%). Interest
shall be calculated from the date payment was due and until actually received by ARIZONA.



 


		4.6	Obligation to Pay Fees. If any patent or patent
claim within Patent Rights is held
invalid in a final decision
by a court of competent jurisdiction and last resort from
which no appeal has or can be taken, all obligation to pay fees based on that patent or claim
or any claim patentably indistinct
therefrom will be reduced by 50% as of the date of final decision. LICENSEE shall not, however, be relieved from paying
full fees that accrued before the final decision, that are based on another patent or claim not involved in the final decision,
or that are based on ARIZONA
's property rights.



 


ARTICLE 5 


Reports
and Inspections


 


		5.1	Books and Records. LICENSEE shall maintain
accurate books and records,
and, upon reasonable advance notice by ARIZONA,
LICENSEE's records shall be open for inspection by ARIZONA
for the purpose of verifying the accuracy
of reports. LICENSEE
shall keep, and cause
SUBLICENSEE(s) to keep, accurate records and books showing
all transactions regarding the use of Licensed Product or sublicensing of Licensed Product and shall permit duly authorized agents
of ARIZONA, during regular
business hours, to inspect
records regarding payments due ARIZONA.
In the event payment is in error by five
percent (5%) or more, LICENSEE shall pay all reasonable documented audit expenses.



 


		5.2	Annual Reporting on Use of Licensed Product.
After the first commercial use of Licensed
Product, LICENSEE shall provide ARIZONA
with an annual written report within 60 days after December 31 and June 30 of each year indicating:



 


		5.2.1	Summary of sales of Licensed Product by LICENSEE, Affiliates, and
assignees during the pertinent reported period and the reported sales by SUBLICENSEE(s) in reports received by LICENSEE during
the pertinent reporting period; and



 


		5.2.2	The payments due, if any, including
the method used to calculate
payments with respect to the sales reported in Paragraph 5.2.1 above.



 






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		5.3	Annual R & D Reporting. Thirty (30) days
after December 31
of each year following the Original Effective Date and continuing annually thereafter, LICENSEE shall submit
to ARIZONA
a progress report covering LICENSEE' s activities related to development and
testing of Licensed Product and obtaining governmental approvals necessary
for marketing and commercial use. Progress
reports are required for each Licensed Product until the first commercial use of any Licensed Product occurs in the United States
and shall again be required if commercial use of any Licensed Product is suspended or discontinued.



 


		5.4	Progress Reports. Progress reports submitted
under Paragraph 5.3 shall include, but are not limited to, the following topics: current schedule
of anticipated events or milestones, market plans for introduction of Licensed
Products, a summary of the value of resources spent in the reporting period and summary of work completed .



 


ARTICLE 6


Infringement


 


		6.1	Infringement Notification. The LICENSEE shall
notify ARIZONA promptly
if any unauthorized use
of Licensed Product or Technical Information comes to the attention of the LICENSEE.
Notification of such infringement shall include reasonable details that would
enable ARIZONA to investigate
and terminate such infringement,
and ARIZONA retains the
right to
terminate such infringement.



 


		6.2	Pursuit of Infringers. Pursuant to this Agreement
and to the provisions of 35 U .S.C.
29 or other statutes, LICENSEE is empowered, and may extend that power to each SUBLICENSEE that is granted exclusive rights within
a particular country or set of countries under the pertinent sublicense agreement (each, an “Exclusive SUBLICENSEE”):



 


		6.2.l	to bring suit in its own
name, without expense to ARIZONA,
and on its own behalf for infringement of presumably valid claims in Patent Rights
or infringement or misappropriation of the Technical Information; and



 


		6.2.2	in any such suit, to enjoin infringement and to collect for
its use, damages, profits, and awards of whatever nature recoverable for
such infringement or misappropriation; and



 


		6.2.3	in any such suit, with
the prior written permission of ARIZONA,
such permission not to be unreasonably withheld, to settle any claim or suit for
infringement of Patent Rights exclusively licensed to LICENSEE
under this Agreement or for infringement or misappropriation
of the Technical Information.



 


LICENSEE
shall notify and seek input from ARIZONA of LICENSEE's
intention to file suit prior to filing thereof. ARIZONA
acknowledges that, as assignee of the Patent Rights and the Technical Information, it may be a necessary party to any suit or legal
proceeding brought by LICENSEE or an Exclusive SUBLICENSEE concerning infringement of the Patent Rights or misappropriation of
the Technical Information. In light of that, ARIZONA agrees to join in any such suit or legal
proceeding in which the pertinent court or tribunal concludes that ARIZONA is a necessary party
to that suit or legal proceeding. In that event, and if ARIZONA so requests, LICENSEE’s
legal counsel must represent ARIZONA, at LICENSEE’s expense, in any consequent legal
proceedings. If the suit or proceeding is brought by an Exclusive SUBLICENSEE, LICENSEE must cause the Exclusive SUBLICENSEE’s
legal counsel to represent Arizona, at no expense to Arizona. If that legal counsel is unable to represent ARIZONA
because of a conflict of interest or other bona fide reason, ARIZONA may engage other competent
legal counsel, at LICENSEE’s expense of all of ARIZONA’s reasonable costs and subject to their reasonable approval,
to represent ARIZONA in any such suit or legal proceeding. If ARIZONA
does not wish to be represented by LICENSEE’s or the Exclusive SUBLICENSEE’s legal counsel for reasons other than a
conflict of interest, ARIZONA may engage competent legal counsel of its own choosing to represent
ARIZONA at ARIZONA’s own expense. In
the event that LICENSEE exercises its rights under this
paragraph, then as between the parties, all recoveries had or obtained in such suit shall belong solely to LICENSEE with the exception
of any earned fees payable to UNIVERSITY as set forth in
this Agreement. LICENSEE agrees to keep ARIZONA
reasonably apprised of the status and progress of any litigation.


 






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		6.3	University Pursuit of lnfringers. In the event
that suit is initially
brought by ARIZONA under
this Article, ARIZONA
agrees that LICENSEE and its SUBLICENSEES may join ARIZONA
as a party plaintiff in any such suit, to be controlled by ARIZONA, each to bear its own attorneys’ fees and costs. If neither
LICENSEE nor any SUBLICENSEE joins as party plaintiff in such suit, then all recoveries had or obtained in such suit shall belong
solely to ARIZONA. If
LICENSEE joins as party plaintiff in such suit, allocation of recoveries had or obtained in such suit shall be in accordance with
terms to be negotiated by the involved parties, such allocation terms being reasonable and negotiated in good faith and subject
to the terms of any pertinent sublicenses. ARIZONA’S
allocation will reflect the degree in which the Patent Rights and Technical Information are utilized by the infringer (the “University
Allocation”). If the involved parties are unable to agree upon the University Allocation on
or before the date ninety (90) days after the date of termination of the pertinent legal proceeding, then either party may submit
the matter to arbitration in accordance with the dispute resolution procedures set forth in Paragraph 14.10.



 


		6.4	LICENSEE Pursuit of
infringers.
In any infringement action commenced under
this Article by LICENSEE or a SUBLICENSEE, the
expenses in such action, including, but not limited to, costs, fees, attorney fees and disbursements,
as between the parties, shall be LICENSEE’s responsibility..



 


		6.5	University Cooperation.
ARIZONA shall cooperate
fully with LICENSEE in connection with any infringement action initiated by LICENSEE or a SUBLICENSEE under this Article, and ARIZONA
agrees promptly to provide reasonable access to all necessary documents and
to render reasonable assistance in response to a written request by LICENSEE.



 


		6.6	Declaratory Judgment. In the event that a
declaratory judgment alleging invalidity or non-infringement of any of the patents included in Patent Rights shall be brought against
LICENSEE or raised by
way of counterclaim or affirmative defense in an infringement suit brought by LICENSEE or an Exclusive SUBLICENSEE under this Article,
LICENSEE and each SUBLICENSEE, pursuant to this Agreement and to 35 U.S.C. 29
or other statutes, is empowered :



 


		6.7.1	to defend the suit in its own name, at its
own expense, and on its own behalf, for presumably valid claims in such patents
; and



 


		6.7.2	in any such suit, to enjoin infringement and to collect
for its use, damages, profits, and awards; of whatever nature recoverable
for such infringement; and



 






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		6.7.3	in any such suit, with the prior written permission
of ARIZONA, such permission not to be unreasonably withheld, to settle
any claim or suit for declaratory judgment
involving Patent Rights.



 


Nothing
in this paragraph shall be construed as limiting
any rights granted to or retained by
either ARIZONA or LICENSEE
under this Article.


 


		6.8	Validity Challenge. In the event of a validity
challenge brought by LICENSEE or an Affiliate, LICENSEE will pay
the reasonable attorneys’ fees and costs of ARIZONA
in such litigation as
they accrue. In the event of a validity challenge brought by a SUBLICENSEE (that
does not otherwise pay ARIZONA
directly pursuant to Paragraph 2.2),
if LICENSEE does not terminate the pertinent sublicense, then LICENSEE will
pay the reasonable attorneys’ fees and costs of ARIZONA
in such litigation as
they accrue.



 


		6.9	Recovery of Punitive Damages.
In the event that LICENSEE recovers punitive
damages in any action
brought under this Article, LICENSEE shall pay to ARIZONA
15% of any recovery.



 


		6.10	No Obligation or Limitations. Nothing contained
within this Article or this Agreement shall be
construed to obligate ARIZONA
to bring any suit or to enforce any rights under this Agreement. Additionally, nothing contained within this Article or this Agreement
shall be construed to limit the ability of ARIZONA
to bring any suit or to
enforce any rights under this Agreement.



 


ARTICLE 7


Term
and Termination


 


		7.1	Term. This Agreement
shall be in effect as of the Effective Date and shall continue until the expiration
of latest expiring Patent Rights. Upon
expiration of the Patent Rights, the licenses and rights granted under this Agreement related to Technical Information, will be
fully-paid, perpetual and irrevocable.



 


		7.2	Termination by
LICENSEE. LICENSEE may terminate this Agreement
by giving ARIZONA
ninety (90) days prior
written notice and including in the notice a declaration that LICENSEE is
no longer, and henceforth
will not be, making commercial
gain from the use of Patent Rights or Technical Information
in the Fields
of Use or in the Territory.



 


		7.3	Termination by ARIZONA.
If LICENSEE breaches any material term
of this Agreement, then
ARIZONA may give written
notice of the breach; and,
if LICENSEE fails to correct the breach
within sixty (60) days
of its receipt of the written notice, then ARIZONA
shall have the right to terminate the
Agreement by written notice to LICENSEE. If exercised by ARIZONA,
this right supersedes the rights granted in Article 2 (Grant).
For purposes of this paragraph, and subject to Section 8.3 below, a breach
of this Agreement shall include failure
to fulfill LICENSEE marketing
requirements under Art.
8 of this Agreement; or after the first commercial use, ceasing the commercial
use of Licensed Product.



 


		7.4	Automatic Termination.
This Agreement will terminate automatically if, during the term of this Agreement,
LICENSEE :



 


		7.4.1	is generally unable to pay its debts as they become due; or



 


		7.4.2	commits any act of bankruptcy; or



 






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		7.4.3	becomes insolvent; or



 


		7.4.4	files a voluntary petition under any bankruptcy or insolvency
act; or



 


		7.4.5	has an involuntary petition under any bankruptcy or insolvency act filed against it which is
not dismissed within ninety (90) days; or



 


		7.4.6	offers any component of the Patent Rights for the benefit of its
creditors; or



 


		7.4.7	terminates its existence.



 


		7.5	Effect of Termination.
Subject to Section 7.6, upon termination of this Agreement; LICENSEE shall
immediately cease use
of the rights granted herein.



 


		7.6	Effect of Termination on Sublicenses.
Upon termination of this Agreement pursuant to Section 7.3 or 7.4 above, each
sublicense granted under this Agreement shall remain in effect, but subject to further action of the parties as specified in this
Paragraph. If the agreement granting the sublicense pertains only to the Patent Rights and the Technical Information, then LICENSEE
shall assign the sublicense to ARIZONA for the exclusive benefit of the ARIZONA,
subject to any required written consent of the SUBLICENSEE to any such assignment and subject to the written consent of ARIZONA,
which will be granted so long as the agreement to be assigned at the time of assignment is consistent with this Agreement (including
without limitation sections 6.8, and 14.7 through 14.11), imposes obligations on SUBLICENSEE that are substantially similar to
the obligations of LICENSEE as set forth in this Agreement, and does not contain provisions that the ARIZONA
is prohibited by law or ABOR policy from agreeing to. If the agreement granting the sublicense under this Agreement also grants
rights and licenses with respect to intellectual property in addition to the Patent Rights and Technical Information (a “Blended
IP Agreement”), then LICENSEE shall continue to be a party to the Blended IP Agreement and to administer it and be liable
to ARIZONA under its terms, but shall pay and assign over to ARIZONA
a portion of any consideration received under the Blended IP Agreement that reflects the degree in which the Patent Rights and
Technical Information are utilized by the SUBLICENSEE in commercialization of products under the Blended IP Agreement (the “University
Portion”). LICENSEE shall exercise its reasonable commercial efforts to cause the SUBLICENSEE under the Blended IP Agreement
to make reports regarding and payments of the University Portion directly to ARIZONA and/or
to negotiate directly with ARIZONA a separate agreement that covers the Patent Rights and Technical
Information, and that terminates the rights and obligations under the Blended IP Agreement pertaining to the Patent Rights and
Technical Information. Promptly after termination of this Agreement, LICENSEE and ARIZONA
will convene a meeting to determine the University Portion and LICENSEE must provide to ARIZONA,
under appropriate confidentiality obligations, any underlying information in LICENSEE’s possession or control that reasonably
relates to that determination. If the parties are unable to agree upon the University Portion on or before the date ninety days
after the date of termination of this Agreement, then either party may submit the matter to arbitration in accordance with the
dispute resolution procedures set forth in Paragraph 14.10. Any rights or licenses granted under the Blended IP Agreement with
respect to LICENSEE’s intellectual property rights shall be unaffected notwithstanding the provisions of this Paragraph.
If, in any event, upon termination of this Agreement pursuant to Sections 7.3 or 7.4, a particular sublicense agreement is not
either assigned to ARIZONA or the payments are assigned
to ARIZONA, in either case as specifically set forth above,
within ninety (90) date after the effective date of termination of this Agreement, then the applicable sublicense will terminate
upon termination of this Agreement and ARIZONA agrees to
negotiate in good faith for a new license directly with the applicable SUBLICENSEE. 



 






    10 


     


    

 


		7.7	No Relief of Obligations Incurred Prior to Termination.
Termination of the Agreement granted
hereunder by either party does not relieve the parties of obligations incurred prior to such
termination.



 


		7.8	Surviving Terms.
Notwithstanding any termination or expiration of this
Agreement, the provisions of Articles 11 [No Warranties], 12 [ Indemnification],
and 13 [Confidentiality] shall survive and shall be enforceable according
to the terms thereof.



 


ARTICLE 8


Due
Diligence


 


		8.1	Obligation to Commercialize. LICENSEE
shall, using best business practice, diligently fill the
market demands for Licensed Products within the Fields of Use and in the Territory. To that end, LICENSEE
shall meet the developmental milestones described in this Article.



 


		8.2	Government Approvals.
LICENSEE shall diligently endeavor to obtain all necessary governmental approvals for
marketing of the first Licensed Product in any country of the Territory within ten (10) years of the Original Effective
Date.



 


		8.3	LICENSEE Marketing
Obligations. LICENSEE shall market Licensed Product within the Fields
of Use within ninety
(90) days of regulatory approval by both the FDA of the Licensed Product for
marketing and the CMS of any CLIA-compliant diagnostic test required by the labeling of the Licensed Product to be used in determining
administration of the Licensed Product. It is acknowledged by the parties that development and marketing and sale of Licensed Products
can be delayed by unforeseen and unusual consequences neither caused by nor under the control of LICENSEE, including by
way of example, but not limitation, regulatory actions, safety concerns, recalls
and the like. Should such delays cause LICENSEE to fail to complete any development activity or milestone within the allotted
time, or cause LICENSEE to suspend marketing or sale of any LICENSED PRODUCT,
the periods allotted may be extended by mutual agreement, following sufficient documentation of such delays by the LICENSEE.



 


		8.4	Should LICENSEE fail to complete
any development activity or milestone within the allotted
time under this Art. 8, LICENSEE
shall have the option to either a) pay ARIZONA
$10,000 per year until the LICENSEE meets
such obligation, such payment due within 30 days of receipt of ARIZONA
's invoice;
or b) accelerate the payments under 4.1.4.1.(a).
Should LICENSEE fail to meet obligations under this Art. 8 for more than three (3) consecutive
years, that failure will constitute a material breach of this Agreement and ARIZONA
may elect to terminate this Agreement in accordance with
Paragraph 7.3.



 


ARTICLE 9


Notices


 


Any
royalty or fee payment, notice, or other communication
required or permitted to be made or to be given to either party under this Agreement shall be sufficiently made or given on the
date of mailing if sent to such party by certified first
class U.S. mail, postage prepaid, addressed to that party
at its address set forth below.


 






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If to ARIZONA:


Tech Transfer
Arizona


The University
of Arizona


University Services
Annex, 4th Floor


PO Box 210300A


Tucson,
Arizona 85721-0300


Attn: UA98-023


Phone: 520-621-5000


Facsimile 520-626-4600


 


If to LICENSEE:


Mr. Jeffrey E.
Jacob, CEO


Cancer Prevention
Pharmaceuticals, Inc. 1760 E. River Road, Suite 250


Tucson, Arizona 85718


Phone: 520-908-7774


Facsimile: 520-232-2191


 


ARTICLE 10 


Assignment


 


		10.1	This Agreement may be assigned by ARIZONA.
This Agreement shall not be assigned by LICENSEE except (a) with the prior written consent of ARIZONA,
which consent shall not be unreasonably withheld; or (b) as part of a sale or transfer of substantially the entire business of
LICENSEE relating to operations which concern this Agreement. Assignment of this Agreement by LICENSEE shall become effective after
written notice by LICENSEE to ARIZONA including the following:



 


		10.1.1	notice that assignment has been made;



 


		10.1.2	name of the assignee;



 


		10.1.3	assignee's acknowledgement of
the terms and conditions of this Agreement; and



 


		10.1.4.	contact information necessary to update
Article 9 (Notices).



 


ARTICLE 11


No
Warranties


 


		11.1	EXCEPT
AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, UNIVERSITIES MAKE
NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO,
WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, AND VALIDITY
OF PATENTED RIGHTS CLAIMS, ISSUED OR PENDING. IT
IS AGREED THAT LICENSEE
ACCEPTS LICENSED PRODUCTS
ON AN "AS IS" BASIS.



 


		11.2	NOTHING IN THIS AGREEMENT, EITHER EXPRESS OR IMPLIED,
OBLIGATES
UNIVERSITIES EITHER TO
BRING OR TO PROSECUTE ACTIONS OR SUITS AGAINST THIRD
PARTIES FOR PATENT INFRINGEMENT OR TO FURNISH ANY KNOW-HOW OR TRADE SECRETS NOT PROVIDED IN UNIVERSITIES’
PATENT RIGHTS OR NOT EXPRESSLY REQUIRED UNDER THIS AGREEMENT.



 






    12 


     


    

 


		11.3	IN NO EVENT
SHALL UNIVERSITIES BE
LIABLE FOR ANY INCIDENTAL, SPECIAL,
OR CONSEQUENTIAL
DAMAGES RESULTING FROM THE EXERCISE OF THIS LICENSE OR THE USE OF THE TECHNICAL INFORMATION OR LICENSED PRODUCTS.



 


		11.4	NO WARRANTY OR REPRESENTATION IS MADE THAT ANYTHING MADE, USED, OR
SOLD UNDER THE TERMS OF THIS AGREEMENT WILL BE FREE FROM INFRINGEMENT OF ANY THIRD PARTY PATENTS.



 


		11.5	THIS
AGREEMENT DOES NOT CONFER
BY IMPLICATION, ESTOPPEL, OR
OTHERWISE ANY LICENSE
OR RIGHTS TO ANY OTHER PATENT OF UNIVERSITIES OTHER
THAN PATENT RIGHTS AS EXPRESSLY STATED HEREIN, REGARDLESS OF WHETHER
SUCH PATENTS ARE DOMINANT
OR SUBORDINATE TO PATENT RIGHTS.



 


ARTICLE 12


Indemnification


 


		12.1	Indemnification of Universities. LICENSEE
shall indemnify, hold harmless and defend UNIVERSITIES,
its officers,
employees, and
agents against any and all claims, suits, losses, damage,
costs, fees, and expenses resulting from or arising out of the exercise of
this Agreement.



 


		12.2	Insurance. LICENSEE ,
at its sole cost and expense, shall insure its activities in connection with
the work related to Licensed Product under this Agreement and obtain, keep in force, and maintain insurance as follows, or an equivalent
program of self-insurance:



 


		12.2.1	Comprehensive
or commercial general liability insurance (contractual liability included) with its minimum limits as follows:
Each Occurrence
$1,000,000; Products/Completed
Operations Aggregate $5,000,000; Personal
and Advertising Injury $1,000,000; and General Aggregate (commercial form only) $5,000,000; or



 


		12.2.2	LICENSEE may obtain and carry commercial general
liability insurance with minimum limit of $1,000,000
per occurrence until first use in humans, including clinical trials. The minimum limit of LICENSEE' s Product Liability
and General Aggregate insurance must be increased to $5,000,000
before the first patient is enrolled in a clinical trial.



 


		12.2.3	The coverage and limits specified above do not in
any way limit the liability
of the LICENSEE under this Agreement. The LICENSEE shall, upon ARIZONA’S written request, furnish ARIZONA with
certificates of insurance showing compliance with all requirements. Except
as provided below, such certificates must: provide for thirty (30) day
advance written notice to ARIZONA of any modification; indicate that UNIVERSITIES have been endorsed as an additional
insured under the coverage specified
above; and include a provision
that the coverage will be primary and will not relate
to nor will be excess over any
valid and collectable insurance or program of self-insurance
carried or maintained by UNIVERSITIES. LICENSEE will not be obligated to require
a SUBLICENSEE to obtain the foregoing endorsements if the SUBLICENSEE is not granted a right to sell Licensed Products in the United
States and if the law or insurance practices of the jurisdiction of that SUBLICENSEE do not permit or provide for such an endorsement.



 






    13 


     


    

 


		12.3	Notification of Claims
or Suits.
ARIZONA shall notify LICENSEE in writing
of any claim or suit
brought against UNIVERSITIES in respect of which UNIVERSITIES intends to invoke
the provisions of this
Article. LICENSEE shall keep ARIZONA informed on a current basis of its
defense of any claims
under this Article.



 


ARTICLE 13


Confidentiality


 


		13.1	Obligations of
Confidentiality. ARIZONA
or LICENSEE as receiving party ("Receiving Party'')
shall safeguard confidential information disclosed by ARIZONA or LICENSEE ("Disclosing
Party") and marked "Confidential" against disclosure to third
parties with the same degree of care as it
exercises with its own
information of a similar
nature . Receiving Party
shall not use such data,
except to perform its
obligations under this Agreement, and shall not disclose such data to
others (except to its
employees, agents, or consultants who are bound to Receiving Party by
a like obligation of confidentiality) without
the express written permission of Disclosing Party, except that
the Receiving Party is
not prevented
from using or disclosing
any of the data that:



 


		13.1.1	Receiving Party can demonstrate
by written records was previously known to it; or



 


		13.1.2	is now or becomes in the future public knowledge other than through
acts or omissions of
the Receiving Party;



 


		13.1.3	is lawfully obtained
by Receiving Party from sources independent of Disclosing
Party; or



 


		13.1.4	constitutes Technical Information disclosed and used pursuant to a sublicense granted by LICENSEE
hereunder, but subject to suitable obligations of confidentiality.



 


The secrecy obligations
of Receiving Party under these terms shall remain in effect for
five (5) years from the termination date of this Agreement.


 


		13.2	Receipt of
Confidential Information.
The obligations of confidentiality and limited
use hereunder apply to
any confidential information of Disclosing Party provided to Receiving Party
relating to the subject
matter of this Agreement,
whether supplied under this Agreement or previously.



 


		13.3	Exclusion. This Agreement itself
cannot be Proprietary Information per the Arizona Public Records Law ARS
39- 121 and
ARS 41-1350.



 


ARTICLE 14


Miscellaneous


 


		14.l	Restriction on Use of Name .
Nothing contained in this Agreement confers any right to use in advertising, publicity, or
other promotional activities any name, trade name, trademark, or other designation of the University of Arizona or UCI (including
contraction, abbreviation, or simulation of any of the foregoing) without express written permission of ARIZONA or UCI, as the
case may be.



 


		14.2	Entire Understanding. This Agreement embodies
the entire understanding of the parties, and there are no other agreements or understandings, either express or implied, between
the parties relating
to the subject matter hereof. No amendment or modification of this Agreement shall be valid
or binding upon the parties unless made in writing and signed on behalf of
each of the parties by their respective duly authorized officers or agents.



 






    14 


     


    

 


		14.3	Headings. The headings and General Understanding of the several
Articles are inserted for convenience of reference only and are not intended to be a part of or affect the meaning or interpretation
of this Agreement.



 


		14.4	Foreign Reporting
or Approval. LICENSEE shall notify ARIZONA
if LICENSEE becomes aware that this Agreement is subject to any applicable U.S. or foreign government reporting or approval requirement.
LICENSEE shall make all necessary filings and pay all costs including, but not limited to, fees, penalties, and all other out-of-pocket
costs associated with such reporting or approval process.



 


		14.5	Export Control.
If applicable, LICENSEE shall observe all applicable United States and foreign laws with respect to the use of Licensed Product
and related technical data in foreign countries, including, without limitation, the Export Administration Regulations.



 


		14.6	Enforceability of
Terms. In case any of the provisions
contained in this Agreement
is held to be invalid, illegal, or unenforceable in any respect, that invalidity,
illegality, or unenforceability will not affect any other provisions of this Agreement, and this Agreement will be construed as
if the invalid, illegal, or unenforceable provisions had never
been contained in it.



 


		14.7	Choice of Law. The terms and conditions of
this Agreement shall be subject to and shall be construed and enforced in accordance with applicable laws
as interpreted by the courts of the State of Arizona.



 


Paragraphs
14.8 through 14.11 are required by the State of Arizona.


 


		14.8	Compliance.
The parties shall comply with all applicable state and federal statutes and
regulations governing
equal employment opportunity, non-discrimination
and immigration.



 


		14.9	Conflict of
Interest. Pursuant to the provisions of
ARS 38-511, ARIZONA may cancel this Agreement
by written notice to the parties if any person substantially involved in obtaining,
drafting or procuring this Agreement for or on behalf of ARIZONA becomes an employee or consultant in any capacity of the other
party/parties to this Agreement within three (3) years after the Effective Date.



 


		14.10	Arbitration. The parties agree that should a dispute arise between them concerning this
Agreement and no party seeks affirmative relief other than money damages in the amount of Fifty Thousand Dollars ($50,000) or less,
exclusive of interest, costs and attorneys' fees, the parties shall submit the matter to arbitration pursuant to the Revised Uniform
Arbitration Act, A.R.S §12-3001 et seq. (the “Act”), whose rules shall govern the interpretation, enforcement,
and proceedings pursuant to this paragraph. Except as otherwise provided in the Act, the decision of the arbitrator(s) shall be
final and binding upon the parties.



 


 


		14.11	State Funding. The
parties recognize that the performance by ARIZONA may be dependent upon the appropriation of funds by the State Legislature of
Arizona. Should the Legislature fail
to appropriate the necessary funds, ARIZONA may cancel its future obligations under this
Agreement without further duty or obligation.
ARIZONA agrees to notify LICENSEE as soon as reasonably possible after the
unavailability of said funds comes to ARIZONA’s attention.



 


		14.12	Performance of Provisions. The failure of
any party hereto at any time or times to require performance of any provisions of this Agreement shall in no manner affect its
right to enforce such provision at a later time.



 






    15 


     


    

 





IN WITNESS WHEREOF, each
party hereto has executed this Agreement in duplicate originals
by their respective and duly authorized officers on the day and year below written.


 


ARIZONA BOARD
OF REGENTS


on behalf of


THE UNIVERSITY
OF ARIZONA


 


/s/ David Allen


By:_________________________


David Allen,
VP,


 Tech Launch
Arizona


 12/19/13


Date:____________________


 


CANCER PREVENTION
PHARMACEUTICALS, INC.


 


Jeffrey E. Jacob


By:___________________________


Jeffrey E. Jacob,
CEO


12/19/13


Date:______________________


 





 



    16 


     


    




 


SCHEDULE
1


Licensed Patents


 


I. DFMO and Sulindac Combination in Cancer Chemoprevention








	ISSUED PATENTS	 	 	 
	Country	Patent No.	Issue Date	Expiration Date
	U.S.	6,258,845 	07/10/2001	3/26/2019


 





	II. Carcinoma Diagnosis and Treatment, Based on ODC1 Genotype	 
	ISSUED PATENTS	 	 	 
	Country	Patent No.	Issue Date	Expiration Date
	U.S.	8,329,636	12/11/2012	1/15/2031
	 	 	 	 
	PATENT APPLICATIONS	 	 	 
	Country	Patent Appln. No.	Filing Date	 
	Australia	AU2010248803	05/14/2010	 
	Canada	2,761,946	05/14/2010	 
	China	CN 2010080031983.5	05/14/2010	 
	Euro	EP2430452	05/14/2010	 
	Hong Kong	12111787.0	05/14/2010	 
	(registration of CN 2010080031983.5)	 	 	 
	Israel	IL0216369	05/14/2010	 
	Japan	JP2012-511052	05/14/2010	 
	U.S.	13/709,753	12/10/2012	 
	 	(continuation of U.S. 8,329,636)		 
	WIPO	WO 2010/132817	05/14/2010	 


 


	III. Cancer Prevention and Treatment Methods Based on Dietary Polyamine Content	 
	ISSUED PATENTS	 	 	 
	Country	Patent No.	Issue Date	Expiration Date
	All are pending as of the Effective Date.	 	 	 
	 	 	 	 
	PATENT APPLICATIONS	 	 	 
	Country	Patent Appln. No.	Filing Date	 
	U.S. 	13/697,984	05/13/2011	 
	Canada	2,799,431	05/13/2011	 
	Euro	EP 2,568,978	05/13/2011	 
	Japan	JP2013-510342	05/13/2011	 
	WIPO	WO 2011/143579	05/13/2011	 
	 	(based on U.S. 61/345,048	05/14/2010)	 
	 	 	 	 
	IV. Predictive Markers for Polyamine Inhibitor Cancer Therapies	 
	ISSUED PATENTS	 	 	 
	Country	Patent No.	Issue Date	Expiration Date
	All are pending as of the Effective Date.	 	 	 
	 	 	 	 
	PATENT APPLICATIONS	 	 	 
	Country	Patent Appln. No.	Filing Date	 
	U.S.	61/719,748	10/29/2012	 


 









    17 


     


    

 


APPENDIX A


 


Limited Liability
Company Interest Warrant to Purchase



Interest of
Cancer Prevention Pharmaceutical, LLC


Warrant Purchase
Agreement


 






    18